BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 22748138 · Received August 8, 2025

    Report

    Report Number
    2016493-2025-103539
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    June 24, 2025
    Report Date
    September 18, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    CORRECTION : IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2025-103539 IS A CONCOMITANT. THE DEVICE WAS AFFECTED DUE TO THE ISSUE OBSERVED ON THE SUSPECT DEVICE CAPTURED IN MANUFACTURER REPORT NUMBER 2016493-2025-103540.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING PRE-PROCEDURE OF TRACHEOSTOMY, NORADRENALINE STARTED THROUGH PUMP. IT WAS RUNNING WITHOUT ISSUE, THEN A CHANNEL ERROR OCCURRED. MOVED INFUSION TO ANOTHER PUMP PROMPTLY. THE PUMP WAS ALSO RUNNING A BLOOD TRANSFUSION AT THE TIME ON ANOTHER CHANNEL. PATIENTS' BLOOD PRESSURE DID DROP FROM A SYSTOLIC OF 95 TO75 MMHG DURING THIS TIME, IMPROVED SWIFTLY WHEN RESTARTED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING PRE-PROCEDURE OF TRACHEOSTOMY, NORADRENALINE STARTED THROUGH PUMP. IT WAS RUNNING WITHOUT ISSUE, THEN A CHANNEL ERROR OCCURRED. MOVED INFUSION TO ANOTHER PUMP PROMPTLY. THE PUMP WAS ALSO RUNNING A BLOOD TRANSFUSION AT THE TIME ON ANOTHER CHANNEL. PATIENTS' BLOOD PRESSURE DID DROP FROM A SYSTOLIC OF 95 TO75 MMHG DURING THIS TIME, IMPROVED SWIFTLY WHEN RESTARTED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065079 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015